TopQ Cutoff Threshold Validation Study for DRI OCT Triton... | NCT03022383

Studies
TopQ Cutoff Threshold Validation Study for DRI OCT Triton Plus

NCT03022383

Sponsor

Topcon Medical Systems, Inc.

Status

Completed

Last Update Posted

Jun 8, 2022Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Healthy Eyes

Interventions

DRI OCT Triton plus

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Feb 2017Actual

Completion Date

Apr 2017Actual

First Submitted Date

Jan 11, 2017

First Submission Date that Met QC Criteria

Jan 13, 2017

First Posted Date

Jan 16, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2022

Last Update Posted Date

Jun 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To determine optimal cut-off value for the TopQ cut-off on the DRI OCT Triton plus

Detailed Description

Scans with a TopQ score below the optimum cut-off should be considered to be poor or unacceptable quality, and scans with a TopQ score above the cut-off should be considered good or acceptable quality. The study will evaluate the predetermined cut-off values by investigating measurement variability of scans.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Subjects Presenting With Normal Eyes		Subjects with no known ocular diseases will be scanned on the DRI OCT Triton Plus device	Device: DRI OCT Triton plus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DRI OCT Triton plus	Device	OCT Machine used for diagnostic purposes	Subjects Presenting With Normal Eyes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement Variability of Signal to Noise Ratio		1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Participants must be at least 18 years of age
Participants must be able to complete all testing (all OCT scans)
Participants must volunteer to be in the study and sign the consent form

Exclusion Criteria

Subject with history of ocular disease or ocular pathology

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with no known eye disease.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wei-Chieh Huang, PhD	Topcon Medical Systems, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Topcon Medical Systems Inc.		Oakland	New Jersey	07436	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided